East End Medical this week announced that it received FDA 510(k) clearance for its SafeCross transseptal radiofrequency (RF) puncture and steerable balloon introducer system.
The Miami-based company designed SafeCross to provide a predictable and safe treatment option for electrophysiology and structural heart interventions requiring left atrial access.
“Transseptal crossing is required for a growing number of catheter-based procedures, including left atrial appendage closure, transcatheter mitral valve repair, and atrial fibrillation ablation. Current septal puncture devices require careful technique, controlled force, and can be challenging in certain anatomies or subsequent procedures,” Dr. Martin Leon, professor of medicine at Columbia University Medical Center, said in a news release. “The SafeCross system can simplify left atrial access and improve safety during these procedures. I am excited for the meaningful impact this innovation will have for patients.”
SafeCross is a 3-in-1 system that has a steerable introducer sheath with an ultra-visible positioning balloon and RF puncture dilator. The contrast-filled positioning balloon is visible under echocardiography and X-ray for precise puncture site selection and the bi-directional steerable introducer sheath allows for safe maneuvering and perpendicular placement on the septum, according to the company.
East End Medical’s SafeCross RF technology delivers electrical energy quickly and predictable to puncture the atrial septum. SafeCross is designed to be compatible with commonly available electrosurgical generators.
“With the rapid growth in left atrium procedures, physicians need a single device to precisely gain transseptal access at specific locations on the septum,” Dr. Vivek Reddy, director of cardiac arrhythmia services for the Mount Sinai Hospital and Health System, said. “The SafeCross system, with the unique steerable balloon and RF puncture, was designed to provide physicians the control required to precisely select sites and puncture the septum in an efficient, safe, and reproducible manner.”
The company is slated to do an initial limited release followed by expanded commercial sales by the end of this year.